Quality Assurance Specialist

2 days ago


india beBeeQuality Full time

Job Title: Quality Assurance SpecialistWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team.About the RoleThe primary focus of this position will be to ensure compliance with regulatory requirements and GCP guidelines.This includes conducting remote monitoring of site regulatory binders, source documentation, and protocol compliance.You will also be responsible for performing source data verification (SDV) comparing CRFs against source documents.Key ResponsibilitiesAudit essential documents including 1572s, training logs, delegation logs, IRB correspondence, and investigator CVs/licenses.Track quality KPIs and generate quality scorecards by site to identify areas for improvement.Develop targeted training on GCP, protocol requirements, and documentation standards.Own the CAPA process from identification through effectiveness checks.Prepare sites for sponsor audits and regulatory inspections through remote review and mock inspections.RequirementsBachelor's degree in a life science or related field.Minimum 2 years of experience in a quality assurance role.Excellent communication and problem-solving skills.BenefitsCompetitive salary and benefits package.



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